Berro Y Cebolla Liquid
NDC Package 53145-080-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Berro Y Cebolla (dextromethorphan hydrobromide, guaifenesin) liquids is shake well before usedo not exceed more than 6 doses in any 24-hour period or as directed by a doctor.AGE                                                                                       Doseadults and children 12 years of age and over                             2 tablespoons (30 mL) every 4 hourschildren 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hourschildren under 6 years of age                                                   consult a doctor. This formulation utilizes a liquid delivery system. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-080 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53145-080-08
Package Description
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Code
53145-080
11-Digit Billing Format
53145008008
RxNorm Crosswalk
  • RxCUI: 1298228 - dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral Solution

Clinical Specifications

Proprietary Name
Berro Y Cebolla DM
Non-Proprietary Name
Dextromethorphan Hydrobromide, Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Shake well before usedo not exceed more than 6 doses in any 24-hour period or as directed by a doctor.AGE                                                                                       Doseadults and children 12 years of age and over                             2 tablespoons (30 mL) every 4 hourschildren 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hourschildren under 6 years of age                                                   consult a doctor

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53145-080-08 identifies a specific commercial package of 1 bottle in 1 carton / 237 ml in 1 bottle of Berro Y Cebolla DM, a human over the counter drug labeled by Menper Distributors, Inc.. This liquid is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Menper Distributors, Inc. on April 01, 2019. The current certification is valid through December 31, 2026.

How is this Menper Distributors, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53145008008. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53145-080-08
11-Digit CMS (5-4-2)
53145-0080-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.